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OpenTrials
Completed

NCT Number: NCT02795377

Hypertension and Injury

Membrane microparticles are submicron fragments of membrane vesicles shed from various cell types. Circulating endothelial microparticles have been proposed as markers of endothelial injury. However, which mechanical forces contribute to their release is not clear.

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Key information

Conditions

Arterial Hypertension CAD Cardiovascular Diseases Hypertension Vascular Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

In a first series subjects (50% hypertensives) with and without arterial hypertension and no Coronary Artery Disease (CAD) (n=50) will be recruited. MP subpopulations will be discriminated by flow cytometry according to the expression of established surface antigens including CD31+/41-, CD144+, and CD62e+. Besides office and ambulatory 24h blood pressure measurements, pulse wave analysis will be performed to determine central blood pressure, augmentation index (AIX), and pulse wave velocity. Endothelial function (Flow-mediated dilation, FMD), arterial pulsatile stretch (fractional diameter changes, FDC), and wall-shear-stress (WSS) will be measured in the same segment of the brachial artery (BA) by ultrasound. In a second series, the investigators will take measurements in subjects with hypertensive crises (SBP>180 mmHg) (n=20) before and after 4h and normalization of arterial BP by urapidil. In a third series, the investigators will take measurement in subjects with stable CAD (n=10) before and after transfemoral coronary diagnostic angiography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male subjects with or without arterial hypertension, hypertensive crises, stable CAD
  • written informed consent

Exclusion criteria

  • subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (CRP>0.6 mg/dl), malignancies, arrhythmias

Treatment and study plan

Primary outcomes

  1. endothelial function

    Time frame: Baseline

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2

  2. Changes in endothelial function

    Time frame: Baseline and after 4 hours

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 3

  3. Changes in endothelial function

    Time frame: Baseline and 4 hours after procedure

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 4 before and after transfemoral coronary diagnostic angiography

Secondary outcomes

  1. Microparticle

    Time frame: Baseline

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 1 and 2

  2. Changes in Microparticle

    Time frame: Baseline and after 4 hours

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 3

  3. Changes Microparticle

    Time frame: Baseline and 4 hours after procedure

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 4 before and after transfemoral coronary diagnostic angiography

  4. Wall Shear Stress

    Time frame: Baseline

    measured by ultrasound in brachial artery for Subgroup 1 and 2

  5. Changes in Wall Shear Stress

    Time frame: Baseline and 4 hours

    measured by ultrasound in brachial artery for Subgroup 3

  6. Changes in Wall Shear Stress

    Time frame: Baseline and 4 hours after procedure

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

  7. changes in fractional diameter (FDC)

    Time frame: Baseline

    measured by ultrasound in brachial artery for Subgroup 1 and 2

  8. changes in fractional diameter (FDC)

    Time frame: Baseline and after 4 hours

    measured by ultrasound in brachial artery for Subgroup 3

  9. Changes in fractional diameter (FDC)

    Time frame: Baseline and 4 hours after procedure

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

  10. pulse wave velocity

    Time frame: Baseline

    measured for Subgroup 1 and 2

  11. Changes in pulse wave velocity

    Time frame: Baseline and after 4 hours

    measured for Subgroup 3

  12. Changes in pulse wave velocity

    Time frame: Baseline and 4 hours after procedure

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

  13. augmentation index

    Time frame: baseline

    measured for Subgroup 1 and 2

  14. Changes in augmentation index

    Time frame: Baseline and after 4 hours

    measured for Subgroup 3

  15. Changes in augmentation index

    Time frame: Baseline and 4 hours after procedure

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

Hypertension, Endothelial Microparticle Release, and Endothelial Function: Role of Pressure, Shear, and Stretch

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2016
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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